Bevacizumab (called also Avastin ®) is a medicine preventing the creation of new blood vessels (a process called "angiogenesis"). This can reduce blood flow of the tumor and then decreasing the contribution of nutriments and oxygen to the cancer cells and prevent the tumor from growing.

In various types of cancers, as lung, breast, colorectal and renal cancer, addition of the bevacizumab to chemotherapy allowed to improve the disease outcome. The bevacizumab already benefits from a marketing authorization (MMA) for these various types of cancers.

The bevacizumab has also obtained MMA for the treatment of the ovarian cancer in its most frequent histological form (ovarian carcinoma). Clinical trials conducted in this indication demonstrated the importance to pursue the treatment by bevacizumab after the chemotherapy is ended.

This anti-angiogenic medicine is thought to be of a potential interest in sex cords- stromal since this tumors are very well vascularized.

The ALIENOR study aims to explore the interest and the clinical benefit of associating bevacizumab to the paclitaxel in order to treat patients suffering from recurring sex cords- stromal tumor treated beforehand by platinum chemotherapy

patients will receive paclitaxel alone at the dose 80 mg/m² administered by intravenous injection at D1, D8 and D15 every 4 weeks for 6 cycles. Thereafter, patients will be followed-up with imaging exams every 12 weeks. At the time of confirmed progression, patients could receive bevacizumab 15 mg/kg every 3 weeks for 12 months following investigator's decision. In some cases, longer therapy may be allowed after discussion with the Principal Investigator/Sponsor

Drug: Paclitaxel

Experimental: B - Paclitaxel + Bevacizumab followed by Bevacizumab

patients will receive paclitaxel at the dose 80 mg/m² administered by intravenous injection at D1, D8 and D15 every 4 weeks + Bevacizumab at the dose 10 mg/kg administered by intravenous injection every 2 weeks (D1 and D15) for 6 cycles. Thereafter, patients will receive IV injection of bevacizumab 15 mg/kg every 3 weeks for up to 1 year

Tumours within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence > 90 days following completion of radiotherapy.

Patients must have been pre-treated with at least 1 prior line of platinum-based chemotherapy

Adequate bone marrow, liver and renal functions including the following:

Ability to understand and sign informed consent and willingness to comply with the study procedures before study entry

Women of childbearing potential* are required to have a negative serum pregnancy test within 7 days prior to study treatment initiation (i.e. Cycle 1 Day 1) and are willing to use adequate contraceptive method during the whole study period and for up to 6 months after the last treatment intake

*: Female patients who meet at least one of the following criteria are defined as women of non-childbearing potential:

Female patient who do not meet at least of the above criteria are defined as women of childbearing potential

Covered by a medical insurance (in country where applicable)

Exclusion Criteria:

Prior systemic therapy with bevacizumab

Active peripheral neuropathy ≥ grade 3 (NCI-CTCAE v4.3)

Prior history of other malignancies other than ovarian SCST (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the subjects has been free of the disease for at least 3 years or 5 years for breast cancer

No resolution of specific toxicities related to any prior anti-cancer therapy to grade ≤1, excluding alopecia, according to the NCI-CTCAE v.4.3

History or evidence of thrombotic or hemorrhagic disorders, including cerebro-vascular accident/stroke or transient ischemic attack or sub-arachnoids' haemorrhage within 6 months prior to first dose of study drugs

Myocardial infarction or instable angina within 6 months prior to first dose of study drugs

NYHA grade ≥ II congestive heart failure

Serious cardiac arrhythmia requiring medication

Peripheral vascular disease ≥ grade 3

History of bowel obstruction, including sub-occlusive syndrome and history of abdominal fistula, gastro-intestinal perforation or intra-abdominal abscess during the year prior to inclusion

Prior treatments:

Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study inclusion or anticipation of need for major surgical procedure during the course of the study

Current or recent treatment with another investigational drug within 30 days of first study treatment dosing or within 6 weeks in case of prior nitrozo-urea and or mitomycin C treatment. In case of hormonotherapy , patients will be eligible if hormonotherapy is discontinued within at least 1 week before treatment initiation

Current or recent (within 10 days prior to randomization) chronic use of aspirin> 325 mg/day or use of any other inhibitor of platelet aggregation

Chronic treatment (i.e. > 15 days) with non steroids anti-inflammatory agents unless a washout period of 15 days was observed before the inclusion.

Intake of granulocyte growth factor within 3 weeks before study entry

Presence of hematuria and proteinuria ≥ 2+ (urine dipstick). Patients with ≥ 2+ proteinuria on dipstick at screening should undergo a 24-hour urine collection and will be eligible only if 24-h proteinuria ≤ 1 g

Any contraindications to paclitaxel treatment: for example severe hypersensitivity reactions to paclitaxel, macrogolglycerol ricinoleate (polyoxyl castor oil) or to any of the excipients (Ethanol Citric acid) (refer to Taxol® SPC for further details)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770301